Spinal implant system and method

ABSTRACT

A spinal implant comprises an implant body extending between an anterior surface and a posterior surface and includes a first vertebral engaging surface and a second vertebral engaging surface. The implant body includes an inner surface that defines at least one cavity that is oriented to implant a fastener oblique relative to a lateral axis of a subject body and adjacent an intervertebral space of the subject body. At least one indicia is disposed with the implant body to facilitate orientation of the implant body with the subject body. Systems and methods are disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefits of U.S. Provisional PatentApplication No. 61/887,794 filed Oct. 7, 2013, the contents of whichbeing hereby incorporated in its entirety by reference.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to aspinal implant system and a method for treating a spine, which employ anoblique pathway.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc hemiation,osteoporosis, spondylolisthesis, stenosis, tumor, and fracture mayresult from factors including trauma, disease and degenerativeconditions caused by injury and aging. Spinal disorders typically resultin symptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, correction, discectomy, laminectomy,corpectomy and implantable prosthetics. As part of these surgicaltreatments, spinal constructs, such as, for example, bone fasteners,spinal rods and interbody devices can be used to provide stability to atreated region. For example, during surgical treatment, surgicalinstruments can be used to deliver components of the spinal constructsto the surgical site for fixation with bone to immobilize a joint.Certain spinal surgery approaches utilize a direct lateral approach toaccess lumbar disc spaces, however, these techniques present certainchallenges due to the location of musculature and neural structuresembedded therein.

This disclosure describes an improvement over these prior arttechnologies with the provision of specialized instrumentation, implantsand techniques to allow for an oblique lateral surgical pathway to thelumbar disc spaces.

SUMMARY

Systems and methods of use for accessing disc spaces via an obliquelateral approach are provided. In some embodiments, a spinal implantcomprises an implant body extending between an anterior surface and aposterior surface and includes a first vertebral engaging surface and asecond vertebral engaging surface. The implant body includes an innersurface that defines at least one cavity that is oriented to implant afastener oblique relative to a lateral axis of a subject body andadjacent an intervertebral space of the subject body disclosed. At leastone indicia is disposed with the implant body to facilitate orientationof the implant body with the subject body.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a plan view of a system for treating a body with a surgicalprocedure;

FIG. 2 is a plan view of a system for treating a body with a surgicalprocedure;

FIG. 3 is a perspective view of components of one embodiment of a systemin accordance with the principles of the present disclosure;

FIG. 3A is a perspective view of the components shown in FIG. 3 withparts separated;

FIG. 4 is a perspective view of components of one embodiment of a systemin accordance with the principles of the present disclosure disposedwith a subject body;

FIG. 5 is a perspective view of components of one embodiment of a systemin accordance with the principles of the present disclosure;

FIG. 5A is a perspective view of components of one embodiment of asystem in accordance with the principles of the present disclosure;

FIG. 6 is a perspective view of components of one embodiment of a systemin accordance with the principles of the present disclosure;

FIG. 7 is an axial view of components of the system and body shown inFIG. 4;

FIG. 8 is a plan view of components of one embodiment of a system inaccordance with the principles of the present disclosure disposed withvertebrae;

FIG. 9 is a perspective view of components of one embodiment of a systemin accordance with the principles of the present disclosure;

FIG. 10 is a plan view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 11 is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 11A is a plan view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 12 is an oblique end view of the components shown in FIG. 11;

FIG. 12A is an oblique end view of the components shown in FIG. 11;

FIG. 12B is a side view of the components shown in FIG. 11 withfasteners;

FIG. 12C is a top view of the components shown in FIG. 11;

FIG. 12D is a top view of the components shown in FIG. 11 withfasteners;

FIG. 13 is a plan view of the components shown in FIG. 16 disposed withvertebrae;

FIG. 14 is a plan view of components of FIG. 16 disposed with vertebraewith fasteners;

FIG. 15 is a plan view of components shown in FIG. 11 disposed withvertebrae;

FIG. 15A is a plan view of the components and vertebrae shown in FIG.15;

FIG. 16 is a perspective view of a component of one embodiment of asystem in accordance with the principles of the present disclosure;

FIG. 17 is a perspective view of components of one embodiment of asystem in accordance with the principles of the present disclosure;

FIG. 18 is a top view of components shown in FIG. 17; and

FIG. 19 is a plan view the components shown in FIG. 17 disposed withvertebrae.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system for implant delivery to a surgical site and amethod for treating a spine, which employ an oblique surgical pathway,which may include an oblique-lateral surgical pathway. In oneembodiment, the systems and methods of the present disclosure areemployed with a spinal joint and fusion, for example, with a cervical,thoracic, lumbar and/or sacral region of a spine.

In one embodiment, the surgical system is employed with a methodincluding an oblique lateral interbody fusion (OLIF) procedure in thelower lumbar region between an L1 vertebral body and an L5 vertebralbody using an antero-lateral operative corridor between a lateral psoasmuscle and an anterior vasculature, such as, for example, the vena cavaand aorta. In one embodiment, the patient is placed on their side, leftside up, so as to position the vena cava on the right side of acenterline. In one embodiment, the surgical system avoids the psoasmuscle thereby avoiding teasing apart the muscle fibers and disruptingnerves located in the psoas muscle in the L1-L5 vertebral region. In oneembodiment, the psoas muscle is numbed and/or paralyzed the surgicalprocedure. In one embodiment, an anterior-most portion of the psoasmuscle is pierced during the surgical procedure.

In one embodiment, the insertion pathway is disposed at an anglerelative to a lateral axis of a patient body. In one embodiment,interbody implants and instruments are provided that facilitatepositioning through the insertion pathway. In one embodiment, aninterbody implant is disposed laterally in the disc space. In oneembodiment, the interbody implant is positioned at an oblique anglerelative to a lateral axis of the subject body. In one embodiment, thesurgical pathway is oriented 0-45 degrees relative to a direct lateralaxis of a subject body. In one embodiment, the surgical pathway isoriented 15-30 degrees relative to the direct lateral axis. In oneembodiment, the surgical instruments are equipped with surgicalnavigation components, such as, for example, emitters mounted with theinstruments and adjacent surgical device sensors employed with surgicalnavigation, microsurgical and image guided technologies may be employedto access, view and repair spinal deterioration or damage. In oneembodiment, a trial is utilized to establish a starting point forinsertion of an interbody implant.

In one embodiment, the surgical system includes an interbody implanthaving flanges that extend along the OLIF pathway for integratedfixation. In one embodiment, the surgical system includes an interbodyimplant with a plate. The interbody implant and plate can be insertedtogether or separately. In one embodiment, the surgical system includesan interbody implant having a zero profile with separate metal platesattached obliquely relative to a longitudinal axis of the interbtodyimplant. In one embodiment, the surgical system includes an interbodyimplant having a zero profile with no plate but includingobliquely-placed integrated fixation elements. In one embodiment, thesurgical system includes an interbody implant including an angled edgecurved towards an oblique surgical pathway.

In one embodiment, the surgical system includes an interbody implanthaving thread locking technology. In one embodiment, the surgical systemincludes an interbody implant having at least one flange that extendsalong the OLIF pathway for integrated fixation. In one embodiment, thesurgical system includes an interbody implant provided with a plate. Inone embodiment, the surgical system includes an interbody implant havingradiopaque markers to facilitate positioning of the interbody implant.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. Also, as used in thespecification and including the appended claims, the singular forms “a,”“an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended daims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the surgical system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference is made in detail to the exemplary embodiments ofthe present disclosure, which are illustrated in the accompanyingfigures. Turning to FIGS. 1-8, there are illustrated components of asurgical system, such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites, depending on the particular application and/orpreference of a medical practitioner. For example, the components ofspinal implant system 10, individually or collectively, can befabricated from materials such as stainless steel alloys, commerciallypure titanium, titanium alloys, Grade 5 titanium, super-elastic titaniumalloys, cobalt-chrome alloys, stainless steel alloys, superelasticmetallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUMMETAL® manufactured by Toyota Material Incorporated of Japan), ceramicsand composites thereof such as calcium phosphate (e.g., SKELITE™manufactured by Biologix Inc.), thermoplastics such aspolyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate such as hydroxyapatite (HA),corraline HA, biphasic calcium phosphate, tricalcium phosphate, orfluorapatite, tri-calcium phosphate (TCP), HA-TCP, calcium sulfate, orother resorbable polymers such as polyaetide, polyglycolide,polytyrosine carbonate, polycaroplaetohe and their combinations,biocompatible ceramics, mineralized collagen, bioactive glasses, porousmetals, bone particles, bone fibers, morselized bone chips, bonemorphogenetic proteins (BMP), such as BMP-2, BMP-4, BMP-7, rhBMP-2, orrhBMP-7, demineralized bone matrix (DBM), transforming growth factors(TGF, e.g., TGF-β), osteoblast cells, growth and differentiation factor(GDF), insulin-like growth factor 1, platelet-derived growth factor,fibroblast growth factor, or any combination thereof.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a fully opensurgical procedure, a minimally invasive procedure, includingpercutaneous techniques, and mini-open surgical techniques to deliverand introduce instrumentation and/or an implant, such as, for example,an interbody implant, at a surgical site within a subject body B of apatient, which includes, for example, a spine having vertebrae V, asshown in FIGS. 1 and 2. In some embodiments, the implant can includespinal constructs, such as, for example, bone fasteners, spinal rods,connectors and/or plates.

Spinal implant system 10 includes an implant body, such as, for example,an interbody cage 12, as shown in FIG. 8. Cage 12 extends between ananterior surface 14 and a posterior surface 16. Anterior surface 14 isconfigured to face an anterior side of body B and be disposed adjacentan anterior portion of vertebrae, such as, for example an anteriorportion A1 of one or more intervertebral spaces of the L2-L5 vertebrallevels of vertebrae V. Posterior surface 16 is configured to face aposterior side of body B and be disposed adjacent a posterior portion ofvertebrae, such as, for example a posterior portion P1 of one or moreintervertebral spaces of the L2-L5 vertebral levels of vertebrae V.

Cage 12 includes a first vertebral engaging surface 18 and a secondvertebral engaging surface 20. Surface 18 may be substantially planarand/or formed with a convex or angled surface and configured to engageendplate tissue of a vertebral body, such as, for example, an endplateE1 of a V1 vertebral level, as shown in FIG. 1. Surface 20 is configuredto engage endplate tissue of a vertebral body, such as, for example, anendplate E2 of a V2 vertebral level, as shown in FIGS. 1 and 8. In someembodiments, surfaces 18, 20 may be rough, textured, porous,semi-porous, dimpled, knurled, toothed, grooved and/or polished suchthat it facilitates engagement with tissue. In some embodiments, thevertebral tissue may include intervertebral tissue, endplate surfacesand/or cortical bone. In some embodiments, surfaces 18, 20 may both beformed with a convex shape to better conform to the anatomy of avertebral endplate.

Cage 12 may have a substantially oval cross section configuration andincludes an inner surface 22 that defines an opening 23 configured toreceive an agent, which may include bone graft (not shown) and/or othermaterials, as described herein, for employment in a fixation or fusiontreatment. In some embodiments, the cross-sectional geometry of cage 12may have various configurations, such as, for example, round,cylindrical, oblong, triangular, rectangular, polygonal having planar orarcuate side portions, irregular, uniform, non-uniform, consistent,variable, horseshoe shape, U-shape or kidney bean shape.

Inner surface 22 defines cavities, such as, for example, a screw hole 24and a screw hole 26, as shown in FIG. 8. In some embodiments, cavities24, 26 may be internally threaded or substantially smooth and/or flat.Screw hole 24 extends along the body of cage 12 in a transverseconfiguration relative to the surfaces of cage 12, described herein, forfixation with tissue. Screw hole 24 is oriented with the body of cage 12in substantial alignment with an oblique surgical pathway P formed inbody B, as described herein. Surgical pathway P is oriented obliquerelative to a lateral axis XL of body B. In some embodiments, surgicalpathway P is disposed at an oblique angle α relative to axis XL. In someembodiments, angle α is in a range of approximately 0-45 degrees. Insome embodiments, substantial alignment of all or only a portion ofscrew hole 24 with all or only a portion of surgical pathway P includesco-axial, spaced apart, offset, angularly offset and/or parallelalignment.

Screw hole 24 defines an axis X1 oriented oblique relative to axis XLsuch that screw hole 24 implants a fastener, as described herein,oblique relative to axis XL and adjacent portion A1. Axis XL lies in acoronal plane CP defined by body B in substantial alignment with one ormore intervertebral spaces of the L2-L5 vertebral levels, as shown inFIG. 2. Axis XL (FIG. 2) also lies in a transverse plane TP, as shown inFIG. 1, defined by body B such that planes CP, TP intersect adjacentaxis XL. Vertebrae V defines a substantially longitudinal axis L, whichlies in a sagittal plane of body B.

Axis X1 is disposed in substantial alignment with surgical pathway P andat an oblique angle α1 relative to axis XL. In some embodiments, angleα1 is in a range of approximately 0-45 degrees. In one embodiment, angleα1 is oriented approximately 15-30 degrees relative to axis XL andsubstantially aligned with surgical pathway P such that screw hole 24 isconfigured to receive a fastener via surgical pathway P. In someembodiments, screw hole 24 is also disposed at an angular orientationrelative to plane CP and/or axis XL such that a fastener is delivered toa surgical site including an intervertebral space of one or more of theL2-L5 vertebral levels via surgical pathway P and oriented to penetrateendplate tissue of a vertebral body, such as, for example, endplate E1.In some embodiments, screw hole 24 and/or the body of cage 12 may bedisposed at an angular orientation relative to plane CP and/or axis XLsuch that a fastener is oriented to penetrate endplate tissue of avertebral body.

Outer surface 25 includes an oblique surface 44 that defines an opening46 disposed in communication and substantial alignment with screw hole24. Oblique surface 44 is oriented with cage 12 and in substantialalignment with surgical pathway P. Opening 46 is configured to guide afastener into screw hole 24 relative to axis XL and in substantialalignment with surgical pathway P. In some embodiments, oblique surface44 is configured for mating engagement with a surgical instrument, suchas, for example, an inserter, which delivers cage 12 adjacent a surgicalsite via surgical pathway P, as described herein. In some embodiments,oblique surface 44 comprises an oblique extension, such as, for example,as shown in FIG. 11, which shows an oblique surface, such as, forexample, a flange 244, such that the proximal/anterior corner of cage 12is asymmetric.

Screw hole 26 extends along the body of cage 12 in a transverseconfiguration relative to the surfaces of cage 12, described herein, forfixation with tissue. Screw hole 26 is oriented with the body of cage 12in substantial alignment with surgical pathway P. In some embodiments,substantial alignment of all or only a portion of screw hole 26 with allor only a portion of surgical pathway P includes co-axial, spaced apart,offset, angularly offset and/or parallel alignment.

Screw hole 26 defines an axis X2 oriented oblique relative to axis XLsuch that screw hole 26 implants a fastener, as described herein,oblique relative to axis XL and adjacent portion A1. Axis X2 is disposedin substantial alignment with surgical pathway P and at an oblique angleα2 relative to axis XL. In some embodiments, angle α2 is in a range ofapproximately 0-45 degrees. In one embodiment, angle α2 is orientedapproximately 15-30 degrees relative to axis XL and substantiallyaligned with surgical pathway P such that screw hole 26 is configured toreceive a fastener via surgical pathway P. In some embodiments, screwhole 26 is also disposed at an angular orientation relative to plane CPand/or axis XL such that a fastener is delivered to a surgical siteincluding an intervertebral space of one or more of the L2-L5 vertebrallevels via surgical pathway P and oriented to penetrate endplate tissueof a vertebral body, such as, for example, endplate E2. In someembodiments, screw hole 26 and/or the body of cage 12 may be disposed atan angular orientation relative to plane CP and/or axis XL such that afastener is oriented to penetrate endplate tissue of a vertebral body.In some embodiments, angle α, α1 and/or α2 may be equal, substantiallyequivalent and/or different. In some embodiments, surgical pathway P,axis X1 and/or axis X2 may be co-axial, spaced apart, offset, angularlyoffset and/or parallel alignment. In some embodiments, system 10 caninclude a screwdriver or inserter comprising navigation components, asshown in FIG. 6, to establish and maintain surgical pathway P and/orensure that the screw placement is avoiding the anterior vasculature orpsoas.

Oblique surface 44 defines an opening 48 disposed in communication andsubstantial alignment with screw hole 26. Opening 48 is configured toguide a fastener into screw hole 26 relative to axis XL and insubstantial alignment with surgical pathway P. In some embodiments, thecross section configurations of screw holes 24, 26 may be, such as, forexample, oval, oblong, triangular, square, polygonal, irregular,uniform, non-uniform, offset, staggered, undulating, arcuate, variableand/or tapered. In some embodiments, surface 22 may have alternatesurface configurations to define cavities, similar to screw holes 24,26, for receiving fasteners, such as, for example, nails, pins orblades, and/or include non-threaded portions.

Spinal implant system 10 includes one or more fasteners 42, such as, forexample, as shown in FIG. 14, for attaching cage 12 to bone, asdescribed herein. In some embodiments, fasteners 42 a and 42 b may beengaged with tissue, such as, for example, the bony structures of avertebral body in various orientations, such as, for example, series,parallel, offset, staggered and/or alternate vertebral levels. In someembodiments, one or more of fasteners 42 may comprise multi-axialscrews, sagittal angulation screws, pedicle screws, mono-axial screws,uni-planar screws, facet screws, fixed screws, tissue penetratingscrews, conventional screws, expanding screws, wedges, anchors, buttons,dips, snaps, friction fittings, compressive fittings, expanding rivets,staples, nails, adhesives, posts, fixation plates and/or posts.

Fastener 42 comprises a first portion, such as, for example, a head anda second portion, such as, for example, an elongated shaft configuredfor penetrating tissue. The head includes an engagement portionconfigured for engagement with a surgical instrument. The shaft has acylindrical cross section configuration and includes an outer surfacehaving an external thread form. In some embodiments, the external threadform may include a single thread turn or a plurality of discretethreads. In some embodiments, other engaging structures may be locatedon the shaft, such as, for example, nail configuration, barbs, expandingelements, raised elements and/or spikes to facilitate engagement of theshaft with tissue, such as, for example, vertebrae.

In some embodiments, all or only a portion of the shaft may havealternate cross section configurations, such as, for example, oval,oblong, triangular, square, polygonal, irregular, uniform, non-uniform,offset, staggered, undulating, arcuate, variable and/or tapered. In someembodiments, the outer surface of the shaft may include one or aplurality of openings. In some embodiments, all or only a portion of theouter surface of the shaft may have alternate surface configurations,such as, for example, smooth and/or surface configurations to enhancefixation with tissue, such as, for example, rough, arcuate, undulating,porous, semi-porous, dimpled, polished and/or textured. In someembodiments, all or only a portion of the shaft may be cannulated.

In some embodiments, system 10 may comprise various surgicalinstruments, such as, for example, drivers, extenders, reducers,spreaders, distractors, blades, clamps, forceps, elevators and drills,which may be alternately sized and dimensioned, and arranged as a kit.In some embodiments, system 10 may comprise the use of microsurgical andimage guided technologies, such as, for example, surgical navigationcomponents employing emitters and sensors, which may be employed totrack introduction and/or delivery of the components of system 10including the surgical instruments to a surgical site. See, for example,the surgical navigation components and their use as described in U.S.Pat. Nos. 6,021,343, 6,725,080, 6,796,988, the entire contents of eachof these references being incorporated by reference herein.

In assembly, operation and use, as shown in FIGS. 1-8, spinal implantsystem 10, similar to the systems described herein, is employed with asurgical procedure for treatment of a spinal disorder, such as thosedescribed herein, affecting a section of a spine of a patient. System 10may also be employed with other surgical procedures. To treat theaffected section of vertebrae V of a subject body B of a patient, body Bis disposed in a side orientation, as shown in FIG. 1, relative to asurgical fixed surface, such as, for example, surgical table Tconfigured for supporting body B. Body B is placed on a side, left sideup such that the vena cava, being oriented to the right of a centerlineof body B, is positioned further away from pathway P. Body B is orientedsuch that the OLIF procedure can be performed obliquely in front ofpsoas muscle to provide direct access to one or more intervertebralspaces of the L2-L5 vertebral levels of vertebrae V while avoidingselected muscular and abdominal anatomical structures, such as, forexample anterior vasculature. In some embodiments, placement of body Bon its side facilitates access to surgical pathway P that is disposed atoblique angle α relative to axis XL. In some embodiments, placement ofbody B on its side facilitates natural movement of the abdominalcontents away for pathway P via the effect of gravity. In someembodiments, placement of body B on its side allows the surgeon toaccess pathway P while standing in a natural and ergonomic posture. Insome embodiments, needle electrodes may be placed in innervated musclesin the legs of body B to monitor affected nerve roots throughout theprocedure.

In some embodiments, electrodes, such as, for example, electrodes usedwith neural integrity monitoring systems, may not be necessary as thepathway P may avoid nerve roots as well as the neural structures in thepsoas muscle that are encountered along a lateral approach. In someembodiments, the psoas muscle is completely paralyzed during thesurgical procedure as there is no need to monitor or located nervespresent in the psoas muscle as the psoas muscle is avoided along theoblique pathway P. Paralyzing the psoas muscle facilitates manipulationand/or retraction of the psoas muscle during the surgical procedure.

As shown in FIG. 1, the L2 and L5 disc spaces, lower ribs and iliaccrest can be marked on the skin as landmarks. In some embodiments, forexample, a single vertebral level procedure, body B is marked 4-10centimeters (cm) anterior to the midsection of the target disc (orapproximately one third of the distance from the top of the liac crestto the umbilicus). A 3 cm to 6 cm vertical, horizontal or obliqueincision 11 is made in tissue of body B. In some embodiments, forexample, a two vertebral level procedure, body B is marked 4-10 cmanterior to the midsection of the intervening vertebral body and anincision 12 is made in tissue of body B. In one embodiment, the lumbarlordosis of the operative levels can be marked on the skin to determinethe angle in line with the disc space.

In some embodiments, the subcutaneous fat layers are dissected until theabdominal musculature is reached. In some embodiments, a mono-polarcautery can be utilized for hemostasis, and a small self-retainingretractor can be used for initial dissection of the skin andsubcutaneous layer. In some embodiments, the external oblique fascia isthe first plane encountered and is the only layer that will need to besharply incised. In some embodiments, a clamp is used to bluntly spreadthrough the fibers of the external oblique, internal oblique, andtransversalis muscles. In some embodiments, dissection is performed inline with the muscle fibers as these muscle layers run in oppositedirections.

In some embodiments, an index finger is utilized to follow the internalabdominal wall posteriorly down to the psoas muscle. In someembodiments, a finger or a blunt instrument is used to sweep theperitoneal contents, including the ureter, which reflects with theperitoneum, and the retroperitoneal fat anteriorly past the anteriorportion of the psoas clearing to the anterior vertebral body.

In some embodiments, direct visualization may be employed in addition totactile feel to ensure a safe approach to the disc space free fromvascular, peritoneal and nerve obstructions. Fat overlying the psoasmuscle is swept in a cephalad and caudal direction as well asdorso-ventral with handheld retractors. Use of hand-held retractorsplaced between peritoneal contents and the probe minimizes the risk ofinjury to ureters and vascular structures anteriorly. In someembodiments, a Kitner or cloth-based dissector may be used to sweep softtissue structures anteriorly. In some embodiments, system 10 may includeindividual retractors, such as, for example, that shown in FIG. 3A, suchthat individual blades b1, b2, b3 may be inserted independently. In someembodiments, system 10 may include retractors such that no further probeis required. In some embodiments, system 10 may include retractorsconstrained via frame or semi-constrained using elastic or partialframe.

In some embodiments, as shown in FIGS. 3, 3A and 4, a surgicalinstrument, such as, for example, a retractor T2 is disposed withincision I1 and/or I2 and in communication with surgical pathway P forspacing tissue. Retractor blades b1, b2, b3 may be insertedsimultaneously as part of a unitary retractor instrument around one ormore intervertebral spaces of the L2-L5 vertebral levels to protectvessels. In some embodiments, as shown in FIGS. 3 and 3A, asemi-constrained retractor system with separable blades may be used tosequentially and/or independently insert blades b1, b2, b3. An anteriorblade b3 is oriented toward the anterior vasculature to secureprotection of the aorta and vena cava. Posterior blades b1 and b2 areoriented toward the psoas to limit muscle creep and protect the muscleand neural elements. Blade b3 may have an elevation that permits directvisualization of a smooth pin placement. In some embodiments, the pin isblunt nosed to push away vascular structures and the threads are smoothto prevent wrapping up soft tissue. In some embodiments, a screw ismalleted or screwed in and secures on one side of blade b1. In someembodiments, blade b3 may be equipped with a curved distal end to sweepand/or elevate vascular structures away from the surgical site. In oneembodiment, anterior blade b3 may be provided with sensors S fordetecting and/or measuring blood flow near the surgical site to ensurethat the most relevant and sensitive vascular structures near thesurgical site are safely separated from the oblique-lateral and/oroblique spinal surgical pathway. Sensors S may include, such as, forexample, piezoelectric elements; ultrasound emitters and/or receivers,flowmeters; oximeters; pulse meters; and/or other available medicaldevices useful for identifying and/or localizing blood vessels. In someembodiments, anterior blade b3 may be clear, translucent, or asubstantially clear material, such as, for example, a clear polymer, toallow a surgeon to directly visualize structures on the anterior side ofanterior blade b3 during the surgical procedure. In some embodiments,blade b3 may also be longer in length than blades b1 and b2 and includea “spoon” shaped or curved end portion to better curve around theanterior side of a vertebral body, which may serve both to protect thevasculature and secure itself in place by more securely abutting thevertebral body.

Blade b3 is disposed with incision I1 and/or I2 and about one or moreintervertebral spaces of the L2-L5 vertebral levels. In someembodiments, an annulotomy and/or discectomy is performed with asurgical instrument with x-ray confirmation of the starting point thatis central on one or more intervertebral spaces of the L2-L5 vertebrallevels. In some embodiments, system 10 includes a semi-constrainedretractor that facilitates minimal tissue pressures on surroundingabdominal structures and provides flexibility such that its bladesrotate on a fixed pin allowing greater degrees of freedom of movementand working angles for a practitioner.

A probe is preferably passed in front of, anterior to, or alternatelythrough the anterior portion of the psoas and into the disc space tosecure its location. In one embodiment, the oblique angle and lordoticangle of the probe as it enters the disc space is assessedpreoperatively and measured intraoperative using image guidance or usinga mechanical or digital protractor. Fluoroscopy, image guidance and/orsurgical navigation, as described herein and shown in FIG. 6, withregard to the components of system 10, is used to confirm proper probealignment into the disc space. In some embodiments, a guide wire isplaced through a cannula into the disc space and positioning isconfirmed with fluoroscopy. In some embodiments, with the guide wireand/or dilators and/or retractors in place and impacted into the annulusfor firm fixation, sequential dilation is used to spread the fibers ofthe abdominal musculature to a diameter of 22 millimeters. Instruments,such as, for example, a Cobb, mallet, shaver, serrated curettes, rasp, aring curette, a uterine curette and/or combo tools are utilized toperform a discectomy of the disc space. The instruments enter body Bobliquely through the retractor and can be turned orthogonally to allowthe surgeon to work orthogonally across the disc space. The disc spaceis distracted until adequate disc space height is obtained.

In some embodiments, an anterior longitudinal ligament (ALL) releaseprocedure can be performed using an OLIF approach post-discectomy. Forexample, loosening the ALL can be performed by placing holes or partialcuts in the ALL such that the OLIF surgical pathway is immediatelycloser to the ALL.

In some embodiments, a discectomy is performed via surgical pathway. Insome embodiments, trial implants are delivered along surgical pathway Pand used to distract one or more intervertebral spaces of the L2-L5vertebral levels and apply appropriate tension in the intervertebralspace allowing for indirect decompression. In one embodiment, a directdecompression of the disc space is performed by removing a portion of aherniated disc. In some embodiments, the size of cage 12 is selectedafter trialing, cage 12 is visualized by fluoroscopy and oriented beforemalleting into intervertebral space. Trialing is utilized to establish astarting point for cage 12 insertion. A trial 1300, as shown in FIG. 5,including a shaft 1308, a bubble level and a sphere 1312 is insertedinto one or more intervertebral spaces of the L2-L5 vertebral levels. Anangle θ of trial 1300 is adjusted until θ equals angle α. Trial 1300 isvisualized in the anterior plane and the lateral plane to adjust sphere1312 position to a center of the disc space while maintaining angle θ.An intersection of shaft 1308 and the vertebral body is marked by point1350. Marked point 1350 is a starting point for insertion of cage 12 atan angle θ. In some embodiments, the inserter 1400 (see FIG. 6) may alsobe equipped with a bubble level 1310 or inclinometer such that theinsertion angle substantially matches the angle θ determined in thetrialing step.

An alternative trialing embodiment is shown in FIG. 5A, the trial 1300includes a cylindrical head 1320 including one or more radiographicmarkers 1321, 1322, 1323, 1324 (such as, for example, tantalum pins).Those markers 1321, 1322, 1323, 1324 could also be used to help alignthe shaft of the trial 1300 in the correct angle (i.e. when the markersare in the center of the vertebral body V in both anteroposterior (AP)and lateral radiographic images, and the near and far markers arealigned). The angle of the trial 1300 shaft may be verified as correctand that position can then be marked (see element 1350) on the vertebralbody V to be used when the implant 12 in inserted. With the trial 1300shown in FIG. 20, the bubble level 1310 may not be necessary to obtainthe correct angle θ. In order to place the cage 12 in the correct thesurgeon need only to center the cage 12 in the vertebral body V andalign the mark on the inserter 1400 shaft with the mark 1350 on thevertebral body V. This would eliminate the need for the bubble level1310 or inclinometer on the inserter 1400 (see FIG. 6). In someembodiments, the trialing instruments of FIGS. 5 and 20 may also beequipped with navigation emitter structures 1410, 1411 (as showngenerally in the inserter 1400 instrument of FIG. 6) to allow forcompatibility with surgical navigation apparatus as further describedherein.

Pilot holes or the like are made in selected vertebra V1, V2 ofvertebrae V adjacent the L2-L5 intervertebral space, via surgicalpathway P, as shown in FIG. 1, for receiving bone fasteners 42, as shownin FIG. 8. An inserter 1400, as shown in FIG. 6, is attached with cage12. Inserter 1400 delivers cage 12 through incision I1 and/or incisionI2 along surgical pathway P adjacent to a surgical site for implantationadjacent one or more intervertebral spaces of the L2-L5 vertebrallevels.

In one embodiment, as shown in FIG. 8, inserter 1400 includes imageguidance and/or surgical navigation to monitor, maintain, adjust and/orconfirm disposal, delivery and/or alignment of the components of system10 along surgical pathway P and/or adjacent to a surgical site. Forexample, the surgical navigation components of system 10 facilitateplacement of cage 12 with an intervertebral space of the L2-L5 vertebrallevels. The surgical navigation components of system 10 include anemitter 1410 configured to generate a signal representative of aposition of inserter 1400 and/or cage 12 connected therewith, forexample, along surgical pathway P and/or adjacent to a surgical sitesuch as an intervertebral space of the L2-L5 vertebral levels. In someembodiments, emitter 1410 may include one or a plurality of emitters. Inone embodiment, emitter 1410 is shaped substantially like the Greekletter pi and comprises four spaced apart emitters 1411, for generatinga signal representing the trajectory of inserter 1400 and/or cage 12relative to a portion of a patient's anatomy and the depth of inserter1400 and/or cage 12 along surgical pathway P and/or adjacent to asurgical site. In one embodiment, emitter 1410 includes at least onelight emitting diode. In some embodiments, emitter 1410 may includeother tracking devices capable of being tracked by a correspondingsensor array, such as, for example, a tracking device that activelygenerates acoustic signals, magnetic signals, electromagnetic signals,radiologic signals. In some embodiments, emitter 1410 may be removablyattached to inserter 1400. In some embodiments, emitter 1410 may beintegrally formed with inserter 1400 such that inserter 1400 is amonolithic, unitary body.

In some embodiments, system 10 includes a tracking device (not shown)having an emitter array including one or a plurality of emitters thatgenerate signals representing the position of various body referencepoints of the patient's anatomy. A sensor (not shown) receives signalsfrom emitter 1410 and the array. The sensor communicates with aprocessor (not shown), such as, for example, a digitizer control unit,which processes the signals from emitter 1410 and the array to provideinformation regarding the trajectory of inserter 1400 and/or cage 12relative to a portion of the patient's anatomy and the depth of inserter1400 and/or cage 12 along surgical pathway P and/or adjacent to asurgical site. The processor sends this information to a monitor, whichprovides a visual representation of the position of inserter 1400 and/orcage 12 along surgical pathway P and/or adjacent to a surgical site toallow the medical practitioner to guide inserter 1400 and/or cage 12 toa desired location within the patient's anatomy.

The monitor is configured to generate an image from a data set stored ina controller, such as, for example, a computer. In some embodiments, thedata set may be generated preoperatively using scanning techniques, suchas, for example, a CAT scanner or MRI scanner. The image data setincludes reference points for at least one body part, such as, forexample, the spine of a patient, which have a fixed spatial relation tothe body part. The processor is connected to the monitor, under controlof the computer, and to inserter 1400 and/or cage 12.

The sensor receives and triangulates signals generated by emitter 1410and the array to identify the relative position of each of the referencepoints and inserter 1400 and/or cage 12. The processor and the computermodify the image data set according to the identified relative positionof each of the reference points during the procedure. The position andtrajectory of inserter 1400 and/or cage 12 provided by emitter 1410 andthe array is processed by the processor and the computer and is visuallydisplayed against the preoperative image data set stored in the computerto provide the medical practitioner with a visual representation of thetrajectory of inserter 1400 and/or cage 12 relative to a portion of thepatient's anatomy and the depth of inserter 1400 within the patient'sanatomy. See, for example, similar surgical navigation components andtheir use as described in U.S. Pat. Nos. 6,021,343, 6,725,080,6,796,988, the entire contents of each of these references beingincorporated by reference herein. Emitter 1410 may be tracked using avariety of surgical navigation systems serving as the tracking device,these systems include, but are not limited to the O-Arm® imaging deviceand StealthStation® surgical navigation device available fromMedtronic®, Inc. In addition, emitters 1410 may be applied to a varietyof instruments in the present disclosure in order to guide and/or checkthe proper oblique trajectory. Emitter 1410 navigated instruments mayinclude, but are not limited to: cage inserters (see FIG. 6), trials1300 (see FIG. 5), driver instruments for fasteners 42 a (see FIG. 12B),probes, discectomy instruments, and/or combinations of such instruments,such as an inserter with integrated screw trajectory guides.

Anterior surface 14 faces an anterior side of body B adjacent anteriorportion A1 and posterior surface 16 faces a posterior side of body B, asdescribed herein. Surface 18 engages endplate tissue of endplate E1 andsurface 20 engages endplate tissue of endplate E2. Screw holes 24, 26are oriented with the body of cage 12 in substantial alignment withsurgical pathway P, as described herein. Screw hole 24 is oriented toreceive a fastener 42 a via surgical pathway P and is disposed at anangular orientation such that fastener 42 a is delivered to theintervertebral space via surgical pathway P and oriented to penetrateendplate tissue of endplate E1, as shown in FIG. 1. Opening 46 guidesfastener 42 a into screw hole 24 relative to axis XL and in substantialalignment with surgical pathway P. Screw hole 26 is oriented to receivea fastener 42 b via surgical pathway P and is disposed at an angularorientation such that fastener 42 b is delivered to the intervertebralspace via surgical pathway P and oriented to penetrate endplate tissueof endplate E2, as shown in FIGS. 1 and 8. Opening 48 guides fastener 42b into screw hole 26 relative to axis XL and in substantial alignmentwith surgical pathway P. A driver (not shown) is disposed adjacent theintervertebral space and is manipulated to drive, torque, insert orotherwise connect bone fasteners 42 a, 42 b adjacent the intervertebralspace. In some embodiments, the driver may include surgical navigationcomponents, as described herein, to establish a screw pathway that issubstantially concurrent with and/or parallel to the surgical approachangle.

Upon completion of a procedure, as described herein, the surgicalinstruments, assemblies and non-implanted components of spinal implantsystem 10 are removed and the incision(s) are closed. One or more of thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiopaque markers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, the use of surgical navigation, microsurgical andimage guided technologies may be employed to access, view and repairspinal deterioration or damage, with the aid of spinal implant system10. In some embodiments, spinal implant system 10 may include one or aplurality of plates, connectors and/or bone fasteners for use with asingle vertebral level or a plurality of vertebral levels.

In one embodiment, spinal implant system 10 includes an agent, which maybe disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft allograft, xenograft, autograft, bone paste,bone chips, Skelite®, and/or bone morphogenetic protein (BMP) to enhancefixation of the components and/or surfaces of spinal implant system 10with vertebrae. In some embodiments, the agent may include one or aplurality of therapeutic agents and/or pharmacological agents forrelease, including sustained release, to treat, for example, pain,inflammation and degeneration. The various cage 12, 212, 312, 412embodiments described herein may also be coated with a variety ofsubstances to promote bone ingrowth or ongrowth, including but notlimited to titanium and hydroxyapatite (HA). In such embodiments,titanium coatings may be applied via a variety of methods, including butnot limited to plasma spray coating and/or mechanical attachment oftitanium plates to form a PEEK/Titanium implant.

In one embodiment, as shown in FIGS. 9 and 10, system 10, similar to thesystems and methods described herein, comprises a spinal constructincluding cage 12, described above, and a plate 132 delivered throughincision II1 and/or 12 along surgical pathway P, as described herein,adjacent to a surgical site for implantation adjacent one or moreintervertebral spaces of the L2-L5 vertebral levels, as shown in FIG.10. Plate 132 includes a portion 138 configured to engage a vertebrallevel V1 and a portion 140 configured to engage a vertebral level V2. Inone embodiment, plate 132 may be attached with cage 12 prior toimplantation or in situ. Plate 132 includes an inner surface 134 thatdefines openings 136 configured to receive fasteners 42, describedherein. Fasteners 42 a are configured for fixation with vertebral levelV2 and fasteners 42 b are configured for fixation with vertebral levelV1. In one embodiment, plate 132 is secured with cage 12 via a fastener.In some embodiments, plate 132 includes a back out prevention element133.

In one embodiment, as shown in FIGS. 11-15A, system 10, similar to thesystems and methods described herein, may comprise a cage 212, 312similar to cage 12 described above. More particularly, cage 312 (showngenerally in FIGS. 13, 14 and 16) may provide a substantiallyzero-profile cage 312 having a thickness measured between the surfaces318, 320 that is substantially equivalent over the extent of the cage312, as shown in FIG. 16. As shown in FIG. 14, cage 312 comprises anoblique portion 344 defining a pair of holes 324, 326 configured forreceiving and guiding fasteners 42 a, 42 b along a generally obliqueangle, such as, for example, α3 and α4 of FIG. 13, into the adjacentendplates, see endplate E2 of the vertebral body V2, into which fastener42 a extends in FIG. 14.

Referring now to FIG. 12, cage 212 is shown as a “hybrid” flangedimplant which is configured to receive and guide a set of 4 fasteners(42 a, 42 b, 42 c, 42 d) along a generally oblique angle, such as, forexample, α3 and α4 of FIG. 15A. More particularly, cage 212 is formedwith a flange 272 defining holes (224, 226) for guiding some of thefasteners into the adjacent vertebral endplates (see fasteners 42 a, 42b). The flange 272 (having an oblique surface) may also define outerholes 264, 274 defined and oriented to guide other fasteners 42 c, 42 dinto side walls of adjacent vertebral bodies (V1 and V2, as shown inFIG. 15).

Referring generally to FIGS. 11, 12, 12A, 12B, and 15, cage 212 extendsbetween an anterior surface 214 and a posterior surface 216. Anteriorsurface 214 is configured to face an anterior side of body B and bedisposed adjacent an anterior portion of vertebrae, such as, for examplean anterior portion A1 of one or more intervertebral spaces of the L2-L5vertebral levels of vertebrae V. Posterior surface 216 is configured toface a posterior side of body B and be disposed adjacent a posteriorportion of vertebrae, such as, for example a posterior portion P1 of oneor more intervertebral spaces of the L2-L5 vertebral levels of vertebraeV. In some embodiments, surface 216 includes an angled surface 216 athat is configured for contouring away from a contra-lateral foramen. Inother embodiments, as shown in FIGS. 17-19, the cage may comprise curved(convex and/or concave anterior and posterior surfaces) to create a moreanatomically-compatible cage footprint that may also more easily beplaced from an oblique surgical angle as described further herein.

Cage 212 includes a first vertebral engaging surface 218 and a secondvertebral engaging surface 220. Surface 218 is configured to engageendplate tissue of a vertebral body, such as, for example, an endplateE1 of a V1 vertebral body, as described herein. Surface 220 isconfigured to engage endplate tissue of a vertebral body, such as, forexample, an endplate E2 of a V2 vertebral body, as shown in FIG. 15A.Surfaces 218, 220 may be substantially planar in some embodiments. Insome embodiments, surfaces 218, 220 may comprise chamfers, radii orother features to aid in insertion and placement between vertebralbodies. Surfaces 218, 220 may also be provided with convexity along thelength and/or width of the cage 212 so as to conform to complementarysurfaces of the vertebral endplates with which they may be engaged.

Cage 212 may be provided with a substantially rectangular cross sectionconfiguration and includes an inner surface 222 that defines an opening223 configured to receive an agent, which may include bone graft (notshown) and/or other materials, as described herein, for employment in afixation or fusion treatment. In some embodiments cage 212 includesradiopaque markers 290 to facilitate positioning of cage 212 andindicate location of a contralateral edge, a leading nose, and aposterior wall of cage 212. In some embodiments, cage 212 includeslinear markers 294 configured to indicate a position of an angledsurface away from a contralateral foramen. In one embodiment, as shownin FIG. 11A, cage 212 includes an angled radiopaque marker 290 a, whichprovides visual indicia of positioning of the contralateral edge of cage212, such as, for example, surface 216 a and/or a leading nose positionand a posterior wall with the ends of marker 290 a.

Inner surface 222 includes internally threaded and/or non-threadedportions that define a screw hole 224 and a screw hole 226. Screw hole224 extends along the body of cage 212 in a transverse configurationrelative to the surfaces of cage 212, described herein, for fixationwith tissue. Screw hole 224 is oriented with the body of cage 212 insubstantial alignment with oblique surgical pathway P formed in body B,as described herein.

Screw hole 224 defines an axis X3 oriented oblique relative to axis XL,described herein, such that screw hole 224 implants a fastener, asdescribed herein, oblique relative to axis XL and adjacent portion A1.Axis XL lies in plane CP defined by body B in substantial alignment withone or more intervertebral spaces of the L2-L5 vertebral levels, asshown in FIG. 13.

Axis X3 is disposed in substantial alignment with surgical pathway P andat an oblique angle α3 relative to axis XL. In some embodiments, angleα3 is in a range of approximately 0-45 degrees. In one embodiment, angleα3 is oriented approximately 15-30 degrees relative to axis XL andsubstantially aligned with surgical pathway P such that screw hole 224is configured to receive a fastener via surgical pathway P. In someembodiments, screw hole 224 is also disposed at an angular orientationrelative to plane CP and/or axis XL such that a fastener is delivered toa surgical site including one or more intervertebral spaces of the L2-L5vertebral levels via surgical pathway P and oriented to penetrateendplate tissue of a vertebral body, such as, for example, an endplateE2. In some embodiments, screw hole 224 and/or the body of cage 212 maybe disposed at an angular orientation relative to plane CP and/or axisXL such that a fastener is oriented to penetrate endplate tissue of avertebral body.

Screw hole 226 extends along the body of cage 212 in a transverseconfiguration relative to the surfaces of cage 212, described herein,for fixation with tissue. Screw hole 226 is oriented with the body ofcage 212 in substantial alignment with surgical pathway P. In someembodiments, substantial alignment of all or only a portion of screwhole 226 with all or only a portion of surgical pathway P includesco-axial, spaced apart, offset, angularly offset and/or parallelalignment.

Screw hole 226 defines an axis X4 oriented oblique relative to axis XLsuch that screw hole 226 implants a fastener, as described herein,oblique relative to axis XL and adjacent portion A1. Axis X4 is disposedin substantial alignment with surgical pathway P and at an oblique angleα4 relative to axis XL. In some embodiments, angle α4 is in a range ofapproximately 0-45 degrees. In one embodiment, angle α4 is orientedapproximately 15-30 degrees relative to axis XL and substantiallyaligned with surgical pathway P such that screw hole 226 is configuredto receive a fastener via surgical pathway P. In some embodiments, screwhole 226 is also disposed at an angular orientation relative to plane CPand/or axis XL such that a fastener is delivered to a surgical siteincluding one or more intervertebral spaces of the L2-L5 vertebrallevels via surgical pathway P and oriented to penetrate endplate tissueof a vertebral body such as, for example, endplate E1. In someembodiments, screw hole 226 and/or the body of cage 212 may be disposedat an angular orientation relative to plane CP and/or axis XL such thata fastener is oriented to penetrate endplate tissue of a vertebral body.In some embodiments, angle α3 and/or α4 may be equal, substantiallyequivalent and/or different. In some embodiments, surgical pathway P,axis X3 and/or axis X4 may be co-axial, spaced apart, offset, angularlyoffset and/or parallel alignment.

Outer surface 225 includes an oblique surface, such as, for example, aflange 244 that defines an opening 246 disposed in communication andsubstantial alignment with screw hole 224. Flange 244 is oriented withcage 212 and in substantial alignment with surgical pathway P. Opening246 is configured to guide a fastener into screw hole 224 relative toaxis XL and in substantial alignment with surgical pathway P. In someembodiments, flange 244 is configured for mating engagement with asurgical instrument, such as, for example, an inserter, which deliverscage 212 adjacent a surgical site via surgical pathway P, as describedherein.

In some embodiments, flange 244 is configured for fixed disposal withcage 212 and can be monolithically formed therewith. In someembodiments, flange 244 is configured for moveable disposal with cage212 such that flange 244 is selectively removable from a portion of cage212 to facilitate placement within the intervertebral space. In someembodiments, flange 244 includes a surface that may be rough, textured,porous, semi-porous, dimpled and/or polished.

In one embodiment, the oblique surface includes a surface 266 includinga flange 268 and a surface 270 including a flange 272. Flange 268 isconfigured to engage a side wall of vertebrae V1 and includes screw hole264. Screw hole 264 is oriented with the body of cage 212 in substantialalignment with oblique surgical pathway P formed in body B, similar tothat described herein. Screw hole 264 defines an axis oriented obliquerelative to axis XL, described herein, such that screw hole 264 implantsa fastener, as described herein, oblique relative to axis XL.

Flange 272 is configured to engage a side wall of vertebrae V2 andincludes a screw hole 274. Screw hole 274 is oriented with the body ofcage 212 in substantial alignment with oblique surgical pathway P formedin body B, similar to that described herein. Screw hole 274 defines anaxis oriented oblique relative to axis XL, described herein, such thatscrew hole 274 implants a fastener, as described herein, obliquerelative to axis XL.

Screw hole 264 is configured to receive fastener 42 c, similar tofasteners 42 described herein, to attached cage 212 to a side wall ofvertebrae V1. Screw hole 274 is configured to receive fastener 42 d,similar to fasteners 42 described herein, to attached cage 212 to a sidewall of vertebrae V2. Spinal implant system 10 includes one or morefasteners 42, as shown in FIGS. 14-15A, for attaching cage 212 withtissue, as described herein. In some embodiments, the oblique surfaceextends to an anterior corner of cage 212 to allow for easier access toscrews along surgical pathway P when cage 212 is in its final/lateralposition with an intervertebral space.

In assembly, operation and use, as shown in FIGS. 13-15A, spinal implantsystem 10, similar to the systems and methods described herein, isemployed with a surgical procedure for treatment of a spinal disorder,such as those described herein, affecting a section of a spine of apatient. Pilot holes or the like are made in selected vertebra V1, V2 ofvertebrae V adjacent one or more intervertebral spaces of the L2-L5vertebral levels, via surgical pathway P, for receiving bone fasteners42 a, 42 b, 42 c, 42 d. An inserter (not shown), attached with cage 212,delivers cage 212 through incision 11 and/or incision 12 along surgicalpathway P adjacent to a surgical site for implantation adjacent theintervertebral space. Anterior surface 214 faces an anterior side ofbody B adjacent anterior portion A1 and posterior surface 216 faces aposterior side of body B, as described herein. Surface 218 engagesendplate tissue of endplate E1 and surface 220 engages endplate tissueof endplate E2.

Screw holes 224, 226, 264, 274 are oriented with the body of cage 212 insubstantial alignment with surgical pathway P, as described herein.Screw hole 224 is oriented to receive a fastener 42 a via surgicalpathway P and is disposed at an angular orientation such that fastener42 a is delivered to the intervertebral space via surgical pathway P andoriented to penetrate endplate tissue of endplate E2, as shown in FIGS.14-15. Opening 246 guides fastener 42 a into screw hole 224 relative toaxis XL and in substantial alignment with surgical pathway P.

Screw hole 226 is oriented to receive a fastener 42 b via surgicalpathway P and is disposed at an angular orientation such that fastener42 b is delivered to the intervertebral space via surgical pathway P andoriented to penetrate endplate tissue of endplate E1, as describedherein. Opening 248 guides fastener 42 b into screw hole 226 relative toaxis XL and in substantial alignment with surgical pathway P.

Screw hole 264 is oriented to receive a fastener 42 c via surgicalpathway P and is disposed at an angular orientation such that fastener42 c is delivered to the surgical site via surgical pathway P andoriented to penetrate sidewall tissue of vertebra V1, as describedherein. Screw hole 264 guides fastener 42 c into sidewall tissue ofvertebra V1 relative to axis XL and in substantial alignment withsurgical pathway P. Screw hole 274 is oriented to receive a fastener 42d via surgical pathway P and is disposed at an angular orientation suchthat fastener 42 d is delivered to the surgical site via surgicalpathway P and oriented to penetrate sidewall tissue of vertebra V2, asdescribed herein. Screw hole 274 guides fastener 42 d into sidewalltissue of vertebra V2 relative to axis XL and in substantial alignmentwith surgical pathway P.

A driver (not shown) is disposed adjacent the L2-L5 intervertebral spaceand is manipulated to drive, torque, insert or otherwise connect bonefasteners 42 a, 42 b, 42 c, 42 d adjacent the intervertebral space. Uponcompletion of a procedure, as described herein, the surgicalinstruments, assemblies and non-implanted components of spinal implantsystem 10 are removed and the incision(s) are closed.

In one embodiment, as shown in FIG. 16, system 10, similar to thesystems and methods described herein, comprises a spinal constructincluding a cage 312, similar to cage 12 discussed herein. Cage 312includes a flat profile configuration. Cage 312 includes a firstvertebral engaging surface 318 and a second vertebral engaging surface320.

Inner surface 322 includes internally threaded and/or non-threadedportions that define a screw hole 324 and a screw hole 326, similar toscrew holes 24, 26 described herein. Screw hole 324 extends along thebody of cage 312 in a transverse configuration relative to the surfacesof cage 312, described herein, for fixation with tissue. Screw hole 324is oriented with the body of cage 312 in substantial alignment with anoblique surgical pathway P formed in body B, as described herein. Outersurface 325 includes an oblique surface 344 that defines an opening 346disposed in communication and substantial alignment with screw hole 324,similar to the spinal constructs described herein.

In one embodiment, as shown in FIGS. 17-19, similar to the systems andmethods described herein, comprises a spinal construct including a cage412, similar to cage 12 discussed herein. Cage 412 includes an angledprofile configuration. In one embodiment, cage 412 is angled towardpathway P to facilitate insertion. Cage 412 includes a first vertebralengaging surface 418 and a second vertebral engaging surface 420. Cage412 includes a proximal end 421 that is biased, angled and/or curvedtoward an oblique approach angle, similar to the surgical pathwaysdescribed herein. Cage 412 includes a posterior, contralateral wall 422bulleting that facilitates insertion along an oblique surgical pathway.In one embodiment, wall 422 is smooth such that there are no sharp edgesnear posterior nerve roots thereby reducing damage to the nerves.

In assembly, operation and use, as shown in FIG. 19, spinal implantsystem 10, similar to the systems and methods described herein, isemployed with a surgical procedure for treatment of a spinal disorder,such as those described herein, affecting a section of a spine of apatient. Pilot holes or the like are made in selected vertebra V1, V2 ofvertebrae V adjacent one or more intervertebral spaces of the L2-L5vertebral levels, via surgical pathway P, for receiving bone fasteners.An inserter T is attached with cage 412, and delivers cage 412 throughan incision along surgical pathway P adjacent to a surgical site forimplantation adjacent the intervertebral space. Surface 418 engagesendplate E1 and surface 420 engages endplate E2. In some embodiments,cage 412 may be obliquely inserted and an inserter is attached andmanipulated along an oblique surgical pathway as described herein tocome through the oblique access such that cage 412 is insertedobliquely. In some embodiments, cage 412 is orthogonally inserted andthe inserter is attached orthogonally to allow a direct lateralinsertion or orthogonal move from the oblique surgical pathway.

The components of cages 12, 212, 312, 412 can be fabricated from avariety of biologically acceptable materials suitable for medicalapplications, including metals, synthetic polymers, ceramics and bonematerial and/or their composites, depending on the particularapplication and/or preference of a medical practitioner. For example,the components of cages 12, 212, 312, 412, individually or collectively,can be fabricated from materials such as stainless steel alloys,commercially pure titanium, titanium alloys, Grade 5 titanium,super-elastic titanium alloys, cobalt-chrome alloys, stainless steelalloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL® manufactured by ToyotaMaterial Incorporated of Japan), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate such as hydroxyapatite (HA), corraline HA, biphasiccalcium phosphate, tricalcium phosphate, or fluorapatite, tri-calciumphosphate (TCP), HA-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations, biocompatible ceramics,mineralized collagen, bioactive glasses, porous metals, bone particles,bone fibers, morselized bone chips, bone morphogenetic proteins (BMP),such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized bonematrix (DBM), transforming growth factors (TGF, e.g., TGF-β), osteoblastcells, growth and differentiation factor (GDF), insulin-like growthfactor 1, platelet-derived growth factor, fibroblast growth factor, orany combination thereof.

It will be understood that various modifications and/or combinations maybe made to the embodiments disclosed herein. Therefore, the abovedescription should not be construed as limiting, but merely asexemplification of the various embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1-20. (canceled)
 21. A spinal implant comprising: an implant bodyextending along a transverse axis between an anterior surface and aposterior surface, at least a portion of the anterior surface and atleast a portion of the posterior surface extending parallel to alongitudinal axis, the longitudinal axis extending perpendicular to thetransverse axis, the implant body further including an oblique surfaceextending oblique to the axes, the oblique surface extending from theanterior surface to the posterior surface, the oblique surface definingat least one screw hole extending oblique to the longitudinal axis,wherein the oblique surface extends oblique to a lateral axis of apatient body, the lateral axis extending parallel to the longitudinalaxis.
 22. The spinal implant recited in claim 21, wherein the at leastone screw hole defines a screw hole extending at an oblique anglerelative to the lateral axis.
 23. The spinal implant recited in claim22, wherein the oblique angle is oriented approximately 0 to 45 degreesrelative to the lateral axis.
 24. The spinal implant recited in claim22, wherein the oblique angle is oriented approximately 15 to 30 degreesrelative to the lateral axis.
 25. The spinal implant recited in claim21, wherein the at least one screw hole defines a first screw hole and asecond screw hole, the second screw hole being spaced apart from thefirst screw hole, the first screw hole extending at a first obliqueangle relative to the lateral axis, the second screw hole extending at asecond oblique angle relative to the lateral axis.
 26. The spinalimplant recited in claim 25, wherein the first and second oblique anglesare each oriented approximately 0 to 45 degrees relative to the lateralaxis.
 27. The spinal implant recited in claim 25, wherein the first andsecond oblique angles are each oriented approximately 15 to 30 degreesrelative to the lateral axis.
 28. The spinal implant recited in claim25, wherein the at least one screw hole further defines a third screwhole and a fourth screw hole, the third and fourth screw holes eachbeing positioned between the first screw hole and the second screw hole.29. The spinal implant recited in claim 28, wherein the third and fourthscrew holes each extend at an oblique angle relative to the lateralaxis.
 30. The spinal implant recited in claim 28, wherein the thirdscrew hole is in communication with the first screw hole and the fourthscrew hole is in communication with the second screw hole.
 31. Thespinal implant recited in claim 21, wherein the anterior surface and theposterior surface each extend from a first vertebral engaging surface toa second vertebral engaging surface, the oblique surface including afirst flange and a second flange, the first flange engaging the firstvertebral engaging surface, the second flange engaging the secondvertebral engaging surface.
 32. The spinal implant recited in claim 21,wherein the anterior surface, the posterior surface and the obliquesurface each extend from a first vertebral engaging surface to a secondvertebral engaging surface, the implant body having a thickness measuredbetween the first vertebral engaging surface and the second vertebralengaging surface, the thickness being substantially equivalent over anentire length and an entire width of the implant body.
 33. The spinalimplant recited in claim 21, wherein the anterior surface comprises afirst arcuate portion, a second arcuate portion and a linear portionbetween the first arcuate portion and the second arcuate portion, thelinear portion extending parallel to the longitudinal axis, the firstarcuate portion terminating at an end surface of the implant body, thesecond arcuate portion terminating at the oblique surface, the endsurface extending parallel to the transverse axis.
 34. The spinalimplant recited in claim 21, wherein the posterior surface comprises afirst arcuate portion, a second arcuate portion and a linear portionbetween the first arcuate portion and the second arcuate portion, thelinear portion extending parallel to the longitudinal axis, the firstarcuate portion terminating at an end surface of the implant body, thesecond arcuate portion terminating at the oblique surface, the endsurface extending parallel to the transverse axis.
 35. A spinal implantcomprising: an implant body extending along a transverse axis between ananterior surface and a posterior surface, the anterior surface and theposterior surface each extending from a first vertebral engaging surfaceto a second vertebral engaging surface at least a portion of theanterior surface and at least a portion of the posterior surfaceextending parallel to a longitudinal axis, the longitudinal axisextending perpendicular to the transverse axis, the implant body furtherincluding an oblique surface extending oblique to the axes, the obliquesurface extending from the anterior surface to the posterior surface,the oblique surface defining at least one screw hole extending obliqueto the longitudinal axis through at least one of the vertebral engagingsurfaces, wherein the oblique surface extends oblique to a lateral axisof a patient body, the lateral axis extending parallel to thelongitudinal axis, and wherein implant body has a thickness measuredbetween the first vertebral engaging surface and the second vertebralengaging surface, the thickness being substantially equivalent over anentire length and an entire width of the implant body.
 36. The spinalimplant recited in claim 35, wherein: the at least one screw holedefines a screw hole extending at an oblique angle relative to thelateral axis; and the oblique angle is oriented approximately 0 to 45degrees relative to the lateral axis.
 37. The spinal implant recited inclaim 21, wherein: the at least one screw hole defines a first screwhole and a second screw hole, the second screw hole being spaced apartfrom the first screw hole, the first screw hole extending at a firstoblique angle relative to the lateral axis, the second screw holeextending at a second oblique angle relative to the lateral axis; andthe first and second oblique angles are each oriented approximately 0 to45 degrees relative to the lateral axis.
 38. A spinal implantcomprising: an implant body extending along a transverse axis between ananterior surface and a posterior surface, the anterior surface and theposterior surface each extending from a first vertebral engaging surfaceto a second vertebral engaging surface at least a portion of theanterior surface and at least a portion of the posterior surfaceextending parallel to a longitudinal axis, the longitudinal axisextending perpendicular to the transverse axis, the implant body furtherincluding an oblique surface extending oblique to the axes, the obliquesurface extending from the anterior surface to the posterior surface,the oblique surface including a first flange and a second flange, thefirst flange engaging the first vertebral engaging surface, the secondflange engaging the second vertebral engaging surface, the obliquesurface defining at least one screw hole extending oblique to thelongitudinal axis through at least one of the flanges, wherein theoblique surface extends oblique to a lateral axis of a patient body, thelateral axis extending parallel to the longitudinal axis.
 39. The spinalimplant recited in claim 38, wherein: the at least one screw holedefines a screw hole extending at an oblique angle relative to thelateral axis; and the oblique angle is oriented approximately 0 to 45degrees relative to the lateral axis.
 40. The spinal implant recited inclaim 38, wherein: the at least one screw hole defines a first screwhole and a second screw hole, the second screw hole being spaced apartfrom the first screw hole, the first screw hole extending at a firstoblique angle relative to the lateral axis, the second screw holeextending at a second oblique angle relative to the lateral axis; andthe first and second oblique angles are each oriented approximately 0 to45 degrees relative to the lateral axis.